Beginning in the early 1970's, it was found that certain medicines could be administered in dry-powder form directly to the lungs by inhalation through the mouth or inspiration through the nose. This process allows the medicine to bypass the digestive system, and in some instances, allows smaller doses to be used to achieve the same desired results as orally ingested medicines.
Various metered dose powdered inhalers (“MDPI”) or nebulizers that provide inhalable mists of medicines are known in the art. Illustrative is the devices disclosed in U.S. Pat. Nos. 3,507,277; 4,147,166 and 5,577,497.
Most of the prior art MDPI devices employ powdered medicine contained in a gelatin capsule. The capsules are typically pierced and a metered dose of the powdered medicine is slowing withdrawn by partial vacuum, forced inspiration of the user or by centrifugal force.
Several MDPI devices, such as that disclosed in U.S. Pat. No. 5,873,360 employs a foil blister strip. Referring to FIG. 1, the foil blister strip 10 includes a plurality of individual, sealed blisters (or pockets) 12 that encase the powdered medicine. The blisters 12 are similarly pierced during operation to release the metered dose of powdered medicine.
As will be appreciated by one having ordinary skill in the art, the provision of an accurate dosage of medicine in each capsule or blister is imperative. Indeed, the U.S. Government mandates 100% inspection of MDPI formulations to ensure that the formulations contain the proper amount of prescribed medicine or drug(s).
Various technologies have been employed to analyze MDPI formulations (i.e., pharmaceutical compositions), such as X-ray diffraction, high-pressure liquid chromatography (HPLC) and UV/visible analysis. There are, however, numerous drawbacks associated with the conventional technologies.
A major drawback of the noted technologies is that most require samples to be collected from remote, inaccessible, or hazardous environments, and/or require extensive sampling that is time consuming and prohibitively costly. A further drawback is that detection of minute amounts of trace elements, including the active ingredient or drug(s), is often difficult or not possible.
It is therefore an object of the present invention to provide a method and system for high-speed, real-time, on-line fluorescent assessment of active ingredients and trace elements.
It is another object of the present invention to provide a method and system for high-speed, real-time, on-line fluorescent detection of minute amounts of active ingredients and trace elements.
It is yet another object of the present invention to provide a method and system for high-speed, real-time, on-line fluorescent determination of the identity and concentration of active ingredients and trace elements.